Compression device and pressure sensor for treatment of abnormal upper esophageal sphincter functionality

ABSTRACT

A compression device is used to increase intra-luminal pressure within the upper esophageal sphincter of a patient in order relieve an impact of an abnormal or defective upper esophageal sphincter anatomy, physiology, or functionality. In one implementation, the compression device is used in conjunction with an external pressure sensing device to determine the external pressure that is to be applied to the cricoid for a specific patient. The compression device can be a means for the management and/or treatment of abnormal upper esophageal sphincter functionality, or a means for strengthening an esophageal sphincter of a subject, or a means for curing esophageal reflux disease of a subject, or a means for improving vocal function in a subject, or a means for managing lung aspiration, or a means for applying cricoid pressure during anesthesia intubation, or a means for stabilizing body structures such as during medical imaging or radiation treatment.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 14/891,117 filed Nov. 13, 2015, which is a 371 application ofPCT/US2014/038060 filed May 15, 2014, which claims priority from U.S.Provisional Patent Application No. 61/824,594 filed May 17, 2013.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

Not Applicable.

BACKGROUND OF THE INVENTION 1. Field of the Invention

This invention relates to the detection, prevention, treatment and cureof gastroesophageal and gastroesophagopharyngeal reflux complications.It also relates to methods for improving vocal function, methods formanaging lung aspiration, methods for applying cricoid pressure duringanesthesia intubation, and methods for stabilizing body structures suchas during medical imaging or radiation treatment.

2. Description of the Related Art

Aspiration of gastric contents into the lung and airway as well asregurgitation of stomach contents into pharynx and larynx is the reasonfor a significant number of office visits and hospitalizations. Althoughmorbidity of this condition is not systematically evaluated, asignificant percent of deaths has been attributed to the aspiration ofgastric content (30-70% of patients with aspiration pneumonia). Inaddition, a substantial number of outpatient visits are prompted byentry of gastric contents into structures above and beyond the esophagusresulting in various complaints and disorders. These include pneumonia,pneumonitis, bronchitis, laryngitis, pharyngitis, otitis media,laryngeal cancer, dental erosion, and asthma, for example. Theseconditions cause symptoms such as chronic cough (reflux is the cause in29% in some studies), frequent throat clearing, sensation of a lump inthe throat (globus), excessive phlegm, hoarse voice, ear ache, fever,and productive cough in case of pneumonia.

The most deleterious regurgitation events and aspirations occur inrecumbent positions and during sleep. For example, nocturnal acid refluxsufferers often grapple with esophagitis and stricture, adenocarcinnomaof the esophagus, respiratory, and ear, nose and throat disorders, aswell as sleep disturbances and diminished quality of life. Thesecomplications during sleep further exacerbate the day-time symptoms ofchronic cough, frequent throat clearing, or other symptoms.

Acid suppressive therapy has been used as a treatment strategy forgastroesophageal and gastroesophagopharyngeal reflux. However, studiesof effective acid suppression using proton pump inhibitors, H2 receptorantagonists have, at best, reported a modest improvement which has beenchallenged by properly designed randomized clinical trials. In someinstances, pharmacologic therapy has been combined with elevation of thehead of the bed or avoidance of eating for three to four hours beforeretiring to sleep but these methods have not given rise to significantimprovements.

Surgical studies of the management of these therapies report success insome patients. These surgical procedures, however, are costly and havesome mortality, but significant morbidity including difficultyswallowing, gas bloat syndrome, diarrhea, weight loss, . . . etc. Thesecomplications frequently necessitate redo or revision of the operation.In addition, these procedures do not last permanently and lose theirefficacy within seven to ten years.

The socio-economic impact of the available medical and surgical therapyfor the reflux induced supra esophageal complications and aspirationsdescribed above is significant and adds many billions to the health careburden.

U.S. Patent Application Publication No. 2013/0090573 describes a deviceand method that overcome the limitations of the gastroesophageal andgastroesophagopharyngeal reflux treatment therapies described above.Specifically, U.S. 2013/0090573 discloses a non-pharmacologic devicethat is used to increase intra-luminal pressure within the upperesophageal sphincter (UES) of a patient, such as a human or animal, inorder to prevent entry of gastric contents into the pharynx, larynx, ora lung. The device uses external pressure to induce intra-luminalpressure within the UES, by compressing the UES between a cricoidcartilage and a cervical vertebrae thereby preventing gastroesophagealand gastroesophagopharyngeal reflux. The induced intra-luminal pressure,however, does not occlude the esophagus under all physiological events.

In view of the advances in gastroesophageal and gastroesophagopharyngealreflux therapy provided by U.S. 2013/0090573, further improvements tothis gastroesophageal and gastroesophagopharyngeal reflux treatmenttechnology are desirable.

SUMMARY OF THE INVENTION

The present invention provides a compression device for reducingpharyngeal reflux in a subject. The compression device includes a frame;a strap having a first end section attached to the frame and an oppositesecond end section attached to the frame, wherein a length of the strapbetween the first end section and the second end section is adjustable;and a cushion disposed on the frame. The strap and frame are configuredto position the cushion over a cricoid of the subject and to apply apredetermined amount of pressure to the cricoid in order to reducepharyngeal reflux in the subject while allowing the subject to open anupper esophageal sphincter of the subject for other physiologicalevents.

The compression device may include an adjustment mechanism for movingthe cushion toward or away from the frame. The adjustment mechanism canvary the curvature of the frame when moving the cushion toward or awayfrom the frame. The adjustment mechanism can be centrally located on theframe. The adjustment mechanism may include a plate and a positionadjustor movably attached to the plate. The position adjustor is locatedon a first side of the frame, and the plate has a first surface and anopposite second surface. The first surface of the plate can be attachedto the cushion, the second surface of the plate can be in contact with asecond side of the frame. The second surface of the plate can includespaced apart outwardly extending walls that contact with the second sideof the frame. The cushion may be removably attached to the first surfaceof the plate using a fastener material.

In one version of the compression device, the position adjustor isrotatable with respect to the plate such that rotation of the positionadjustor in a first direction moves the cushion toward the frame androtation of the position adjustor in a second direction moves thecushion away from the frame. One of the position adjustor and the platecan include an internally threaded hole, and the other of the positionadjustor and the plate can include an externally threaded post, whereinthe internally threaded hole engages the externally threaded post fortranslation of the position adjustor relative to the plate.

In one version of the compression device, the first end section of thestrap is looped through a slot of the frame for attaching the first endsection of the strap to the frame. An amount of the strap looped throughthe slot of the frame can be varied to adjust the length of the strapbetween the first end section and the second end section of the strap.The amount of the strap looped through the slot of the frame can bevaried by using a fastener material that can removably engage the strap.The second end section of the strap can be attached to a clasp forsecuring the second end section of the strap to the frame. The secondend section of the strap can be looped through a slot of the clasp forattaching the second end section of the strap to the clasp. The firstend section of the strap and the second end section of the strap may beremovably attached to the frame.

The present invention also provides a pressure sensing device that canbe used with the compression device for determining a configuration ofthe compression device suitable for an individual patient. The pressuresensing device includes a pouch defining an interior space containing aspacing insert and a fluid; a conduit having a first end in fluidcommunication with the interior space of the pouch; and a pressuresensor in fluid communication with a second end of the conduit whereinthe pressure sensor and the pouch and the conduit define a fluid tightclosed volume. The pressure sensor may include a sensing layer and asensing element in contact with the sensing layer wherein the sensingelement generates a pressure signal when the fluid applies pressure tothe sensing layer. The pressure sensing device also includes a displaydevice; and a controller in electrical communication with the pressuresensor and the display device. The controller executing a stored programto: (i) receive the pressure signal from the pressure sensor; (ii)correlate the pressure signal to an applied pressure on the pouch; and(iii) display the applied pressure on the display device.

In one version of the pressure sensing device, the sensing layercomprises a silicon diaphragm. The sensing layer may have a first sideand an opposite second side, wherein the first side senses a pressure ofthe fluid and the second side senses ambient atmospheric pressure. Thesensing element can be a strain gauge such that the pressure signal isan output voltage.

In one version of the pressure sensing device, the pouch comprises twopieces of polymeric film having a thickness in the range of 0.001 to0.020 inches, the pouch has a surface area of about 1 to about 10 squareinches, and the interior space of the pouch has a volume of about 0.01cubic inches to about 1 cubic inch. The pouch and the conduit can beheat sealed together, may be disposable, and can be provided inpackaging. The insert can have a perimeter similar in shape to aperimeter of the pouch.

The pressure sensing device may include a housing, wherein the housingcontains the pressure sensor and the controller, and the housingsupports the display device. The conduit can be removably connected tothe housing using a Luer taper connection.

In the pressure sensing device, the fluid is used to take the pressuremeasurement. The pouch, conduit and pressure sensor are singular in thatthere is one sealed pouch, conduit and pressure sensor. The sealed pouchis unsupported and floats between two surfaces. The sealed pouchsurfaces are soft, and sealed pouch deformation is not part of thepressure measurement. The pressure sensing device is mobile, small,lightweight, self-contained with one hand operation, and automaticoperation after the on button is pushed.

The present invention also provides an esophageal sphincter compressionkit comprising a compression device including a cushion; and a pressuresensing device configured to measure pressure between the cushion and aneck of a subject when the pressure sensing device is positioned betweenthe cushion and the neck of the subject. The compression device may be acompression device according to the present disclosure. The pressuresensing device may be a pressure sensing device according to the presentdisclosure. The sealed pouch of the pressure sensing device is placed inan exact anatomical position (e.g., on the cricoid cartilage) when usingthe kit. The sealed pouch of the pressure sensing device bag is of apredetermined volume, specific to the desired application (e.g.,reducing pharyngeal reflux in a subject) of the compression device.

The present invention also provides a method for reducing reflux abovean upper esophageal sphincter of a subject by increasing anintra-luminal pressure of the upper esophageal sphincter of the subject.In the method, a pressure sensing device is positioned on the neck ofthe subject over a cricoid of the subject. A compression device is usedto apply an external pressure to the pressure sensing device until thepressure sensor denotes that the pressure is within a predeterminedrange. The denoted pressure is associated with a value of an indicatorof the compression device. The pressure sensing device and compressiondevice are removed from the subject; and the compression device isreapplied around the neck of the subject according to the value suchthat the cushion applies pressure to the cricoid of the subject. Thevalue may indicate alignment of two reference lines on an adjustablestrap of the compression device. The predetermined range of pressure canbe 10-70 mm Hg, preferably 20-30 mm Hg. The predetermined range ofpressure correlates to an amount of pressure to the cricoid that reducespharyngeal reflux in the subject while allowing the subject to open theupper esophageal sphincter for other physiological events. Thepredetermined range of pressure may correlate about 1:1 to the amount ofpressure to the cricoid that reduces pharyngeal reflux in the subjectwhile allowing the subject to open the upper esophageal sphincter forother physiological events. In the method, the compression device may bea compression device according to the present disclosure, and thepressure sensing device may be a pressure sensing device according tothe present disclosure.

The present invention also provides a method for strengthening anesophageal sphincter of a subject. The method uses a compression deviceincluding (i) a frame, (ii) a strap having a first end section attachedto the frame and an opposite second end section attached to the frame,and (iii) a cushion disposed on the frame. The compression device ispositioned around a neck of the subject such that the cushion appliespressure on the neck that is transmitted to the esophageal sphincter ofthe subject. For a plurality of times, the compression device is removedfrom the subject, and the compression device is reapplied around theneck of the subject such that the cushion applies pressure on the neckthat is transmitted to the esophageal sphincter of the subject. Asresult of this periodic use of the compression device, the esophagealsphincter of the subject is strengthened. The compression device may bepositioned around the neck of the subject while the subject is sleeping.In the method, the compression device may be a compression deviceaccording to the present disclosure. Although the compression devicewill most often be worn at night, certain physicians may believe that asubject will need and will wear the compression device during the day.Certain doctors may say up to 40% of subjects will wear the compressiondevice during the day. Thus, while the compression device is primarily anight time device, the compression device can/will also be utilized/wornduring the day.

In the method for strengthening an esophageal sphincter of a subject,the method also include the step of placing an electrode in contact withthe neck of the subject, placing an electrical pulse generator inelectrical communication with the electrode, activating the electricalpulse generator to generate a series of electrical pulses from theelectrode such that the series of electrical pulses electricallystimulate the esophageal sphincter of the subject. The electrode may beattached to the cushion.

In the method for strengthening an esophageal sphincter of a subject,the method may also include the step of placing one or more electrodesadjacent the esophageal sphincter, placing an electrical pulse generatorin electrical communication with each electrode, activating theelectrical pulse generator to generate a series of electrical pulsesfrom the electrode(s) such that the series of electrical pulseselectrically stimulate the esophageal sphincter of the subject.

In the method for strengthening an esophageal sphincter of a subject,the method may also include the step of placing one or more electrodesin the esophageal sphincter, placing an electrical pulse generator inelectrical communication with the electrode(s), activating theelectrical pulse generator to generate a series of electrical pulsesfrom the electrode(s) such that the series of electrical pulseselectrically stimulate the esophageal sphincter of the subject.

The present invention also provides a method for strengthening an upperesophageal sphincter of a subject. The method includes the steps ofplacing one or more electrodes near the upper esophageal sphincter ofthe subject; placing an electrical pulse generator in electricalcommunication with each electrode; and activating the electrical pulsegenerator to generate a series of electrical pulses from theelectrode(s) such that the series of electrical pulses electricallystimulate the upper esophageal sphincter of the subject. In the method,the electrode(s) can be placed in contact with a neck of the subject. Inthe method, the electrode(s) can be placed on an esophagus of thesubject. In the method, the electrode(s) can be placed in the upperesophageal sphincter of the subject.

The present invention also provides a method for curing esophagealreflux disease of a subject. The method uses a compression deviceincluding (i) a frame, (ii) a strap having a first end section attachedto the frame and an opposite second end section attached to the frame,and (iii) a cushion disposed on the frame. The compression device ispositioned around a neck of the subject such that the cushion appliespressure to a cricoid of the subject. For a plurality of times, thecompression device is removed from the subject, and the compressiondevice is reapplied around the neck of the subject such that the cushionapplies pressure on the cricoid of the subject. As result of thisperiodic use of the compression device, esophageal reflux disease of thesubject is cured. The compression device may be positioned around theneck of the subject while the subject is sleeping. In the method, thecompression device may be a compression device according to the presentdisclosure.

The present invention also provides a method for improving vocalfunction in a subject. In the method, a cushion of a compression deviceis positioned over a voice box region of a neck of the subject such thatthe compression device applies pressure to the voice box region of theneck of the subject. In the method, the compression device may be acompression device according to the present disclosure

These and other features, aspects, and advantages of the presentinvention will become better understood upon consideration of thefollowing detailed description, drawings and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram depicting a sagittal cross section of anose, mouth, pharynx, and larynx of a patient;

FIG. 2 is a schematic diagram depicting a transverse cross section of apatient's neck encircled by one example implementation of a device thatcompresses the UES of the patient;

FIG. 3a is a perspective view of yet another example implementation of adevice that compresses the UES of the patient;

FIG. 3b is a side view of the device of FIG. 3 a;

FIG. 4 is a perspective view of an another example cushion used tocompress the UES of the patient;

FIG. 5 is a side view of the cushion of FIG. 4;

FIG. 6 is a right rear perspective view of yet another exampleimplementation of a device that compresses the UES of the patient;

FIG. 7 is a right front perspective view of the device of FIG. 6;

FIG. 8 is a top rear exploded perspective view of the device of FIG. 6with the strap removed;

FIG. 9 is a top front exploded perspective view of the device of FIG. 6with the strap removed;

FIG. 10 is a top view of a pressure sensing device suitable for use withthe device of FIG. 6;

FIG. 11 is a right rear perspective view of the hand held unit of thepressure sensing device of FIG. 10 with the sensor tubing and attachedsensor pouch removed;

FIG. 12 is a side exploded view of the hand held unit of the pressuresensing device of FIG. 11;

FIG. 12A is a cross-sectional view of the pressure sensor of the handheld unit of the pressure sensing device of FIG. 11 taken along line12A-12A of FIG. 12.

FIG. 13 is a cross-sectional view of the hand held unit of the pressuresensing device of FIG. 11 taken along line 13-13 of FIG. 11;

FIG. 14 is a schematic diagram depicting a transverse cross section of apatient's neck encircled by the compression device of FIG. 6;

FIG. 15 is a summary of a method for compressing the UES of a patient toreduce gastroesophageal and gastroesophagopharyngeal reflux; and

FIG. 16 is a graph depicting variations in intra-luminal pressure duringawake and sleep stages of a patient suffering from gastroesophageal andgastroesophagopharyngeal reflux.

Like reference numerals will be used to refer to like parts from Figureto Figure in the following description of the drawings.

DETAILED DESCRIPTION OF THE INVENTION

A non-pharmacologic device is used to increase intra-luminal pressurewithin the upper esophageal sphincter (UES) of a patient, such as ahuman or animal, in order to prevent entry of gastric contents into thepharynx, larynx, or a lung. The device uses external pressure to induceintra-luminal pressure within the UES, by compressing the UES between acricoid cartilage and a cervical vertebrae and preventinggastroesophageal and gastroesophagopharyngeal reflux. The inducedintra-luminal pressure, however, does not occlude the esophagus underall physiological events. The compression device is used to maintain theintra-luminal pressure of the patient within a predetermined range,continuously reinstating the competency of the UES over a period oftime. In certain implementations, the intra-luminal UES pressure isinduced by applying an external pressure to a patient's cricoidtransferring a compressive force through the intermediary tissue of thepatient towards the UES, increasing its intra-luminal pressure.

In certain implementations, the intra-luminal UES pressure is keptwithin the predetermined range while the patient is asleep. Normalresting pressure of the UES is about 40 mm Hg in the elderly and about70 mm Hg in the young. The driving pressure of the majority of refluxevents are less than 20 mm Hg. During sleep, the intra-luminal UESpressure may decline to approximately 10 mm Hg, potentially renderingthe UES incompetent to maintain the barrier against aspiration. Here,the compression device may be used to induce the intra-luminal pressureto remain within a range that is about 10-70 mm Hg, such as about 20-40mm Hg during sleep, for example. Therefore, the induced intra-luminalpressure effectively prevents gastroesophageal reflux from entering thepharynx and subsequently in the larynx and the lung during sleep. Theterms “UES pressure,” “intra-luminal pressure,” and “intra-luminal UESpressure” are used interchangeably herein.

Referring to FIG. 1, a schematic diagram depicting a sagittal crosssection 100 of a nose, mouth, pharynx, larynx, and esophagus of apatient. The cricoid cartilage is a semi-circular cartilage just abovethe trachea 112. The posterior portion of the cricoid 106 is locatedjust anterior to the UES of the esophagus 108 and is typically broaderthan the anterior portion of the cricoid 104 that sits just inferior tothe thyroid cartilage 102 (Adam's apple) in the neck. Thecrico-pharyngeous muscle, the main component of the UES (not shown) is a“C” clamp-shaped muscle that attaches to the posterior lamina of thecricoid just distal to the thyroid cartilage 102. Behind thecrico-pharyngeous muscle is the cervical vertebrae 110. Therefore,crico-pharyngeous muscle, the main component of the UES and chiefbarrier against reflux and aspiration into the airway, is locatedbetween the vertebrae and the cricoid cartilage giving rise to theopportunity for increasing the UES intra-luminal pressure by externalapplication of pressure onto the cricoid cartilage.

In one implementation, a non-invasive UES compression device is used inconjunction with an external pressure sensing device (collectively“kit”) to determine the external pressure that is to be used within apredetermined range for a specific patient. The non-invasive UEScompression device can be used to apply an external pressure thatchanges the intra-luminal pressure of the patient within thepredetermined range.

Referring to FIG. 2, a schematic diagram depicts a transverse crosssection 200 of an example UES compression device 202 applied to apatient's neck 204. The UES compression device 202 in FIG. 2 isillustrated as having an inflatable cuff 208, a gauge 210, and a bulb212 for manual insertion of pressurized air into the inflatable cuff208. The inflatable cuff 208 can be inflated by squeezing the bulb 212.The pressure produced by the cuff 208 can then be read using the gauge210. The gauge 210 may be connected to the cuff 208 via a tube that islong enough for the patient to be able to read the gauge 210. In otherimplementations, the bulb 212 may be replaced with means toautomatically insert pressurized air into the inflatable cuff 208, suchas an air pump. The inflatable cuff 208 may have a coupling means 214 tocouple the two ends of the inflatable cuff together when wrapped aroundthe neck of the patient. Examples of the coupling means 214 include ahook-and-loop fastener, a fastener with female and corresponding maleconnectors, or mechanical securement devices, for example.

Referring to FIGS. 3a and 3b , another example of the UES compressiondevice 400 is depicted. The UES compression device 400 includes acushion 402 and a band 404. Here, the UES compression device 400 employsa hook-and-loop means (e.g., a Velcro® fastener) to couple the first end406 and second end 408 of the band 404 together. The first end 406 isshown in FIG. 3a as the loop end and the second end 408 is shown as thehook end of the hook-and-loop fastener. Once coupled, the length alongthe long axis of the band 404, of the UES compression device 400 isdirectly related to the intra-luminal pressure. Alternatively, or incombination, the length is varied to obtain the desired intra-luminalpressure by applying less external pressure. In certain implementations,the length of the cushion 402 along the long axis of the cushion 402 anda thickness of the cushion 402 is configured to apply minimal externalpressure to the vascular structures within the neck, such as the carotidartery or the jugular veins. For example, the thickness of the cushion402 allows for a gap of air between the compression device 400 and theneck in the proximity of the vascular structures. Here, the band 404bridges over the carotid and jugular vein avoiding compression of thesevital organs. The aforementioned bridge is between the cushion andsternocleidomastoid muscle.

The implementations disclosed are non-limiting. Other implementationsare also contemplated. For example, the implementation in FIGS. 3a and3b may have a different type of coupling means that resembles the claspof a belt buckle, or the material of the UES compression device 400 maybe elastic. Moreover, the features of the various implementations may bemixed and matched such as utilizing the tightening means in oneimplementation in another implementation.

FIGS. 4 and 5 illustrate an implementation of the cushion 500 that mightbe employed with the UES compression devices 200 or 400. FIG. 4 is aperspective view and FIG. 5 is a side view of the cushion 500. Thecushion 500 has a recession 502 that dimples the medial 504 portion ofthe cushion 500. When the cushion 500 is placed over the anteriorportion of the patient's neck, the recession 502 is positioned over thetracheal cartilage (“Adam's Apple”) of the patient's neck and the areajust beneath the recession 502 is positioned over the cricoid. In thismanner, recession 502 can act as an anchor, preventing displacement ofthe cushion during sleep. This can assist in maintaining the pressureagainst the cricoid within the predetermined range.

Turning now to FIGS. 6 to 9, yet another example of a compression device600 is shown. The compression device 600 has a frame 610 that cancomprise a polymeric material such as polyethylene, polypropylene,nylon, polyester, acrylonitrile butadiene styrene, and the like. Theframe 610 has a central section 612 with a central aperture 613. A firstsection 616 of the frame 610 extends laterally from the central section612. The first section 616 has a outer end 618 with a vertical slot 619,and the first section 616 has an inner end 621 with an arcuate recess622. On the side of the first section 616 opposite the recess 622, thereare mounting slots 623. A second section 626 of the frame 610 extendslaterally from the central section 612. The second section 626 has anouter end 628 with a vertical slot 629, and the second section 626 hasan inner end 631 with an arcuate recess 632. On the side of the secondsection 626 opposite the recess 632, there are mounting slots 633.

Still referring to FIGS. 6 to 9, the compression device 600 has anadjustment plate 652 having an externally threaded post 654 with acentral internally threaded hole 655. The adjustment plate 652 has afirst wall 658 with a protrusion 659, and a laterally spaced apartsecond wall 661 with a protrusion 662. The compression device 600 alsohas a spacer 664 with an opening 665, and has a dial 667 with aninternally threaded throughhole 668. The compression device 600 has ascrew 670 and a washer 671, and an adjustment knob 673.

The adjustment plate 652, the spacer 664, the dial 667, the screw 670,the washer 671, and the adjustment knob 673 can be assembled into acurvature adjustment mechanism for the frame 610 as follows. On one sideof the frame 610, the protrusion 659 and the protrusion 662 of theadjustment plate 652 are positioned in one of the mounting slots 623 andone of the mounting slots 633, respectively. The spacer 664 ispositioned in contact with the central section 612 of the frame 610 onthe opposite side of the frame 610. The dial 667 is positioned incontact with the spacer 664 between the arcuate recess 622 and thearcuate recess 632 of the frame 610. The screw 670 is assembled in thewasher 671, and the screw 670 is passed through the throughhole 668 ofthe dial 667, through the opening 665 of the spacer 664, through theaperture 613 of the frame 610, and into the threaded hole 655 of theadjustment plate 652. The adjustment knob 673 can be snapped on the dial667.

The adjustment mechanism for the frame 610 functions as follows. Thecentral section 612 of the frame 610 has a reduced front to rearthickness compared to the front to rear thickness of the first section616 and the second section 626 of the frame 610. As a result, the firstsection 616 and the second section 626 of the frame 610 can flex withrespect to the central section 612 of the frame 610 in directions A andB as shown in FIG. 8. When the adjustment knob 673 is rotated in one ofthe directions R in FIG. 7, movement of the externally threaded post 654of the adjustment plate 652 in the internally threaded throughhole 668of the dial 667 due to engagement of the threads of the post 654 and thethroughhole 668 causes the adjustment plate 652 and the dial 667 to movetogether. When the adjustment knob 673 is rotated in the oppositedirection of directions R in FIG. 7, movement of the externally threadedpost 654 of the adjustment plate 652 in the internally threadedthroughhole 668 of the dial 667 causes the adjustment plate 652 and thedial 667 to move apart.

As detailed above, the protrusion 659 and the protrusion 662 of theadjustment plate 652 are positioned in one of the mounting slots 623 andone of the mounting slots 633 of the first section 616. This causescontact of the first wall 658 of the adjustment plate 652 with the firstsection 616 of the frame 610, and causes contact of the second wall 661of the adjustment plate 652 with the second section 626 of the frame610. When the adjustment plate 652 and the dial 667 move together, thefirst wall 658 of the adjustment plate 652 moves the first section 616of the frame 610 in direction A of FIG. 8 with respect to the centralsection 612 of the frame 610, and the second wall 661 of the adjustmentplate 652 moves with the second section 626 of the frame 610 indirection A of FIG. 8 with respect to the central section 612 of theframe 610. Due to the elastic property of the central section 612 of theframe 610, when the adjustment plate 652 and the dial 667 move apart,the first section 616 of the frame 610 moves in direction B of FIG. 8with respect to the central section 612 of the frame 610, and the secondsection 626 of the frame 610 moves in direction B of FIG. 8 with respectto the central section 612 of the frame 610. The choice of left handedor right handed threads for the externally threaded post 654 of theadjustment plate 652 and the internally threaded throughhole 668 of thedial 667 determines whether rotation of the adjustment knob 673 in theclockwise direction of directions R in FIG. 7 causes movement indirection A or direction B for the first section 616 and the secondsection 626 of the frame 610.

The compression device 600 has a fastener material 678, such as the hookor loop fastening material of a Velcro® fastener. The compression device600 has a cushion 680 that may be fastened to the adjustment plate 652by the fastener material 678. The hook and loop portions of thefastening material 678 can each be secured to the adjustment plate 652and the cushion 680 by adhesive or other suitable means.

Looking at FIGS. 6 and 7, the compression device 600 has a strap 684including a first fastener 686 and a second fastener 688 that may eachcomprise the hook and loop fastening materials of a Velcro® fastener. Afirst reference line 690 and a plurality of additional reference lines692 are also provided on the strap 684. The compression device 600 alsohas fastening clasp 694. A first end 696 of the strap 684 is insertedthrough a slot 698 of the clasp 694 and secured to the strap 684 by thefirst fastener 686. A second end 697 of the strap 684 is insertedthrough slot 629 of the frame 610 and secured to the strap 684 by thesecond fastener 688. An end 699 of the clasp 694 is fastened in the slot619 of the frame 610.

The length of the cushion 680 along the long axis of the cushion 680 anda thickness of the cushion 680 is configured to apply minimal externalpressure to the vascular structures within the neck, such as the carotidartery or the jugular veins. For example, the thickness of the cushion680 allows for a gap of air between the compression device 600 and theneck in the proximity of the vascular structures. Here, the frame 610and the strap 684 bridge over the carotid and jugular vein avoidingcompression of these vital organs. The aforementioned bridge is betweenthe cushion 680 and sternocleidomastoid muscle.

Turning now to FIGS. 10-13, any of the compression devices 200, 400, 600can be used in conjunction with a pressure sensing device 700 todetermine the external pressure that is to be used within thepredetermined range for a specific patient. The pressure sensing device700 has a housing 702 including a top section 704 and a bottom section705 held together by screws 707. Inside the housing 702, a battery 709is held in battery clips 711 that are in electrical communication with aprinted circuit assembly 713. A digital display 715 is in electricalcommunication with the printed circuit assembly 713. A contact 717 is inelectrical communication with the printed circuit assembly 713, and anon button 719 moves the contact 717 for turning on or off the digitaldisplay 715.

A pressure sensor 721 is in electrical communication with the printedcircuit assembly 713, and the pressure sensor 721 has a tubular inlet722. A conduit 724 places the inlet 722 of the pressure sensor 721 influid communication with a tubular outlet 727 of a male fitting 726 thatis positioned between the top section 704 and the bottom section 705 ofthe housing 702. Looking at FIG. 12A, the pressure sensor 721 includes acase 772 having a cover 773. The pressure sensor 721 includes a sensinglayer in the form of a silicon diaphragm 774. The sensing layer has afirst side 791 and an opposite second side 792. The first side 791 ofthe diaphragm 774 contacts a gel die coat 778, and the second side 792of the diaphragm 774 faces an opening 782 of the case 772. A sensingelement 775 in the form of a strain gauge is connected to the diaphragm774. An electrical lead 776 is in electrical communication with thesensing element 775 via a wire 777.

A female fitting 729 connects to the male fitting 726 to place a lengthof tubing 731 in fluid communication with the pressure sensor 721. Inone non-limiting example, the tubing 731 comprises transparentpolyurethane, has a length of 12 inches, and has an inside diameter of0.094 inches. A pouch 733 is secured with a fluid tight seal to a distalend of the tubing 731, and an open cell foam insert 735 is positioned inan interior space of the pouch 733. The interior space of the pouch 733is in fluid communication with the tubing 731. In one non-limitingexample, the pouch 733 is formed by RF heat sealing around a perimeterof two pieces of polyurethane film having a thickness of about 0.006inches. The top piece 734 of polyurethane film is shown in FIG. 10, andthe bottom piece (not shown) of polyurethane film has a perimetersubstantially the same as the top piece 734. In the non-limiting exampleshown in FIG. 10, the pouch 733 has a main section 737, and has aconnection section 738 that facilitates a fluid tight seal (e.g., a heatseal) with the tubing 731. In one non-limiting example, the main section737 of the top piece 734 of the pouch 733 has a surface area of about 1square inch. In one non-limiting example, the foam insert 735 comprisesa 0.125 inch thick section of polyurethane open cell foam that has aperimeter shape similar to the perimeter shape of the main section 737of the pouch 733. In one non-limiting example, the main section 737 ofthe pouch 733 has a volume of about 0.125 cubic inches.

Operation of the pressure sensing device 700 proceeds as follows. Thetubing 731 with the female fitting 729 and attached pouch 733 arepreferably provided as a disposable item in packaging. The femalefitting 729 is connected to the male fitting 726. In one non-limitingexample, the female fitting 729 and the male fitting 726 use a Luertaper connection. The connection creates a fluid (e.g., air) tight pathbetween the pressure sensor 721 and the pouch 733. The connection iscreated at ambient atmospheric pressure such that the pressure withinthe tubing 731 and the pouch 733 is about atmospheric pressure.

The on button 719 is depressed to power up the printed circuit assembly713 and turn on the digital display 715. A controller on the printedcircuit assembly 713 can be programmed to provide continuous read out ofpressure on the digital display 715 until the on button 719 is depresseda second time. Alternatively, the controller on the printed circuitassembly 713 can be programmed to provide continuous read out ofpressure on the digital display 715 for a set time period beforeautomatic power turn off. In one non-limiting example, automatic powerturn off occurs two minutes after the on button 719 is depressed. Thepouch 733 of the pressure sensing device 700 is then positioned betweentwo surfaces, and as the surfaces move together to contact and applypressure by compressing the pouch 733, the volume in the pouch 733decreases thereby increasing pressure within the pouch 733 and attachedtubing 731. The pressure sensor 721 senses the pressure increase, andthe controller on the printed circuit assembly 713 executes a storedprogram to provide a read out of the applied pressure on the pouch 733on the digital display 715 in mm Hg. The pressure sensor 721 may sensethe pressure at fixed time intervals (e.g., 16 times a second).

Looking at FIGS. 12 and 12A, the tubing 731 is in fluid communicationwith an opening 781 in the case 772 of the pressure sensor 721. Thefirst side 791 of the diaphragm 774 senses a pressure of the fluidwithin the pouch 733 and attached tubing 731 via gel die coat 778. Thesecond side 792 of the diaphragm 774 senses ambient atmospheric pressurevia opening 782. A differential pressure measurement as an outputvoltage is obtained in which the pressure applied to the first side 791of the diaphragm 774 is measured against the ambient atmosphericpressure. Specifically, applying pressure to the diaphragm 774 resultsin a resistance change in the strain gauge sensing element 775, which inturn causes a change in the output voltage in direct proportion to theapplied pressure on the diaphragm 774.

Looking now at FIG. 14, the pouch 733 of the pressure sensing device 700is shown positioned between a patient's neck 204 and the cushion 680 ofthe compression device 600 of FIGS. 6 to 9. The pouch 733 is put intocontact with the anterior portion of the patient's neck 204 over thecricoid. The frame 610 of the compression device 600 is positioned suchthat the cushion 680 contacts the pouch 733. The strap 684 is placedaround the neck 204, and the clasp on the strap 684 is fastened in theslot 619 of the frame 610 to secure the compression device 600 aroundthe neck 204. In one non-limiting example, the main section 737 of thetop piece 734 of the pouch 733 and the contact surface 682 of thecushion 680 have about the same surface area (e.g., about 1 squareinch). The pressure exerted on the pouch 733 and cricoid is varied byunfastening the first end 696 from the strap 684, moving the strap 684through the slot 698 of the clasp 694, and then refastening the firstend 696 to the strap 684 by way of first fastener 686. The firstreference line 690 and the plurality of additional reference lines 692provide a visual indication of the tension on the strap 684. Forexample, when the first reference line 690 and a reference line 692nearest the clasp 694 are aligned, a lower tension on the strap 684 anda lower pressure on the pouch 733 and cricoid are exhibited compared towhen the first reference line 690 and a reference line 692 furthest fromthe clasp 694 are aligned.

Referring now to FIG. 15, a flow diagram summarizes a method 800 forcompressing the upper esophageal sphincter of a patient to reducegastroesophageal and gastroesophagopharyngeal reflux during sleep. Atstep 802, the pouch 733 of the pressure sensing device 700 is attachedto the anterior portion of the patient's neck 204 over the cricoid. Acushion 680 (which may be removed from packaging) is secured to theadjustment plate 652 of the frame 610 of the compression device 600. Theframe 610 of the compression device 600 is then positioned such that thecushion 680 contacts the pouch 733. The strap 684 is placed around theneck 204, and the clasp 694 on the strap 684 is fastened in the slot 619of the frame 610 to secure the compression device 600 around the neck204.

At a step 804, the compression device 600 is used to apply an externalpressure to the cricoid of the patient. The external pressure is variedby unfastening and refastening the first end 696 and/or the second end697 to the strap 684 at different positions until the digital display715 of the pressure sensing device 700 denotes that the pressure of theUES is within a predetermined range, such as between about 10-70 mm Hg,preferably 20-30 mm Hg. This predetermined range is ideally in a rangethat allows the upper esophageal sphincter to open to vent gas or allowsbelching, or allows swallowing or high pressure vomiting. Studies haveconfirmed that the pressure displayed on the digital display 715 of thepressure sensing device 700 has about a 1:1 relationship to theintra-luminal pressure for a specific patient. This 1:1 relationship canbe achieved with suitable programming of the controller, e.g., theprinted circuit assembly 713.

At a step 806, the value of an indicator can be associated with theapplied external pressure. For example, the alignment of the firstreference line 690 and one of the plurality of additional referencelines 692 on both sides of the strap 684 can be the indicator.

At the step 810, the compression device 600 is removed from thepatient's neck such that the external pressure is removed. At the step812, the value for the indicators is prescribed. In this manner, anintra-luminal pressure sensor is not required to determine if theappropriate external pressure is being applied to induce theintra-luminal pressure that is within the predetermined range.

The clasp 694 allows the patient to unfasten the strap 684 from theframe 610 and then refasten the strap 684 to compress the upperesophageal sphincter at the prescribed pressure for a duration of time,such as during sleep for example. The patient, or agent thereof, can usethe value of the indicator to reattach the strap 684 to the frame 610and the clasp 694 in the prescribed position after removal of the strap684 from the frame 610 (such as for washing).

A practitioner (e.g., a nurse or doctor) may use the steps of FIG. 15and a kit (e.g., a compression device 600 and a pressure sensing device700) to determine a prescription to reduce gastroesophageal andgastroesophagopharyngeal reflux in a patient during sleep. Thepractitioner notes which of the plurality of additional reference lines692 of the strap 684 of the compression device 600 aligns with the firstreference line 690 on each side of the strap 684 when the strap 684 ispositioned to produce the desired intra-luminal pressure (step 806). Thepractitioner prescribes that the UES compression device 600 is to beintermittently worn at the selected alignment of the reference lines bythe patient for a duration, such as during sleep (step 812). Theprescription may be for the patient to use the UES compression devicefor a period of time, such as several days (nights), weeks, months,years, or a lifetime.

In some implementations, the patient may return to repeat the steps 802through 812. Therefore, from time to time, the prescription may needadjusting and/or a new prescription may need to be given. However, theadjustment mechanism for the frame 610 as described above can allow apatient to easily make smaller scale adjustments in the pressure such asfor comfort. When a patient wearing the compression device 600 rotatesthe adjustment knob 673 in one direction R of FIG. 7 (e.g., clockwise),the first section 616 of the frame 610 moves in direction A of FIG. 8with respect to the central section 612 of the frame 610, and the secondsection 626 of the frame 610 moves in direction A of FIG. 8 with respectto the central section 612 of the frame 610. This results in an increasein pressure on the cricoid. When a patient wearing the compressiondevice 600 rotates the adjustment knob 673 in the opposite direction Rof FIG. 7 (e.g., counterclockwise), the first section 616 of the frame610 moves in direction B of FIG. 8 with respect to the central section612 of the frame 610, and the second section 626 of the frame 610 movesin direction B of FIG. 8 with respect to the central section 612 of theframe 610. This results in a decrease in pressure on the cricoid. Thus,without intending to limit the scope of the invention, the prescriptionsteps of FIG. 15 could be described as “macro pressure adjustment”, andthe use of the adjustment knob 673 of the adjustment mechanism of theframe 610 of the compression device 600 could be described as “micropressure adjustment”. The “macro pressure adjustment” provided by thestrap 684 can also be done by the patient. The number of turns of theadjustment knob 673 can be correlated to some adjustments in pressure.For example, two full turns of the adjustment knob 673 may cause twomillimeters of movement of the frame 610 and a corresponding change inpressure.

Referring to FIG. 16, a graph depicts variations in pressure; the UESduring awake and sleep stages of a patient suffering fromgastroesophageal and gastroesophagopharyngeal reflux. The Y-axis depictsthe intra-luminal pressure in mm Hg and the X-axis depicts time measuredin hours. The two graph lines show the intra-luminal pressure of thepatient using a UES compression device (graph line 902) and not using aUES compression device (graph line 904). The resting level of theintra-luminal pressure for the patient is denoted at pressure 912, whichis typically about 40 mm Hg. For the patient using the UES compressiondevice, the compression device begins applying pressure to the cricoidof the patient at time 908 shown on graph line 902. The intra-luminalpressure is increased until the value of the indicator is at aprescribed level 910. At time 906, the patient begins to fall asleep.For the patient using the UES compression device, as the patient fallsasleep the intra-luminal pressure decreases to the predetermined levelthat is induced by the compression device. In contrast, for the patientnot using the UES compression device, the intra-luminal pressuredecreases to approximately 10 mm Hg or below and remains atapproximately 10 mm Hg or below (graph line 904 at pressure level 914)throughout the sleeping stage, leaving the patient susceptible toanother episode of gastroesophageal and gastroesophagopharyngeal reflux.Graph line 902 in FIG. 16 shows the rise in intra-luminal pressure to beabout equal to the fall in intra-luminal pressure as the patient usingthe compression device falls asleep. However, the rise and fall may havedifferent values (e.g., 30 mm Hg rise as the patient tightens thecompression device and 20 mm Hg fall as the patient falls asleep or visaversa). In certain implementations, the UES compression device is usedto increase the intra-luminal pressure while the patient is asleep,raising the intra-luminal pressure from approximately 10 mm Hg toapproximately 40 mm Hg, for example. In certain implementations, the UEScompression device is reusable. In other implementations, the UEScompression device is disposable.

The invention is not limited to the management or treatment of abnormalupper esophageal sphincter functionality. For example, the compressiondevice 600 can provide a means for strengthening an esophageal sphincterof a subject. The term “subject” means an animal such as a mammal,preferably a human. A subject's lower or upper esophageal sphincter maybe weakened due to disease or aging. This may make it difficult for theesophageal sphincter to stay closed. A leaky lower and/or upperesophageal sphincter may result. The compression device 600 can be usedin a method for strengthening an esophageal sphincter of a subject. Inthe method, the compression device 600 is positioned around a neck ofthe subject such that the cushion 680 applies pressure on the neck thatis transmitted to an esophageal sphincter of the subject. The step ofpositioning the compression device 600 can be repeated a number oftimes, for example, each night when the subject sleeps. The compressiondevice 600 acts on the esophageal sphincter in a manner analogous toisometric exercise whereby the esophageal sphincter of the subject isstrengthened. A subject with a strengthened upper esophageal sphinctermay no longer require use of the compression device.

The compression device 600 can be used in conjunction with electricalstimulation to strengthen the esophageal sphincter of the subject. Forexample, one or more electrodes can be placed in contact with a cricoidregion of the neck of the subject. The electrode(s) can be separate fromthe compression device 600, or the electrode(s) can be attached to apart of the compression device 600 such as the cushion 680. Anelectrical pulse generator is placed in electrical communication witheach electrode. The electrical pulse generator is activated to generatea series of electrical pulses from each electrode, wherein the series ofelectrical pulses electrically stimulate the esophageal sphincter of thesubject, thereby strengthening the esophageal sphincter. Thus, thecompression device 600 can be part of a system that can be used tocreate electric impulses targeted at the UES at periodic intervals so asto improve muscle function of the UES. In another version of usingelectrical stimulation to strengthen the esophageal sphincter of thesubject, the one or more electrodes is implanted on a surface of theesophagus adjacent the esophageal sphincter. In yet another version ofusing electrical stimulation to strengthen the esophageal sphincter ofthe subject, the one or more electrodes is placed in the upperesophageal sphincter of the subject.

The compression device 600 also provides a means for curing esophagealreflux disease of a subject. In the method, the compression device 600is positioned around a neck of the subject such that the cushion 680applies pressure on the neck that is transmitted to an esophagealsphincter of the subject. The step of positioning the compression device600 can be repeated a number of times, for example, each night when thesubject sleeps. The compression device 600 acts on the esophagealsphincter in a manner analogous to isometric exercise whereby theesophageal sphincter of the subject is strengthened. Without intendingto be bound by theory, it is hypothesized that as a result of thisstrengthening of the esophageal sphincter, esophageal reflux disease ofthe subject can be cured.

The compression device 600 also provides a means for improving vocalfunction in a subject. It is estimated that laryngectomies numberbetween 50,000 and 100,000. A speech pathologist works with those havinga laryngectomy to recover or improve vocal function. The speechpathologist can work to find a pressure spot over a voice box region onthe neck where vocal function in a subject is improved. The compressiondevice 600 is then positioned over the voice box region of the neck ofthe subject such that the cushion 680 applies pressure to the spot overthe voice box region of the neck of the subject. Vocal function of thesubject is thereby improved.

The compression device 600 may also be used in the followingapplications: (1) assistance during mechanical ventilation to managelung aspiration due to involuntary lack of cognitive control of the UES;(2) positioning or stabilizing of neck internal anatomical structuresthrough the use of a mechanical assist device for injury or traumarecovery; (3) positioning or stabilizing of neck internal anatomicalstructures through the use of a mechanical assist device for surgicalrecovery; (4) assistance to apply cricoid pressure during anesthesiaintubation using the Sellick maneuver and for rapid sequence induction;(5) positioning or stabilizing to immobilize subject neck duringradiation treatment sessions and to avoid radiation overexposure tosurrounding tissue leading to more targeted tumor treatment; and (6)positioning or stabilizing to apply consistent pressure that manipulatesinternal anatomical structures into optimal image position duringultrasound or other CT or MRI imaging wherein this may apply to otheranatomical structures other than neck where the assist device can bepositioned around, for example, the neck, head, shoulder, arm, or legextremities.

Although the invention has been described in considerable detail withreference to certain embodiments, one skilled in the art will appreciatethat the present invention can be practiced by other than the describedembodiments, which have been presented for purposes of illustration andnot of limitation. Therefore, the scope of the appended claims shouldnot be limited to the description of the embodiments contained herein.

What is claimed is:
 1. A method for strengthening an esophagealsphincter of a subject, the method comprising: (a) providing acompression device including (i) a frame, (ii) a strap having a firstend section attached to the frame and an opposite second end sectionattached to the frame, and (iii) a cushion disposed on the frame; (b)positioning the compression device around a neck of the subject suchthat the cushion applies pressure on the neck that is transmitted to theesophageal sphincter of the subject; and (c) repeating step (b) aplurality of times whereby the esophageal sphincter of the subject isstrengthened.
 2. The method of claim 1 wherein: step (b) occurs whilethe subject is sleeping.
 3. The method of claim 1 wherein: a length ofthe strap between the first end section and the second end section isadjustable, a clasp is attached to the second end section of the strap;and the clasp is configured to fasten the strap to the frame to positionthe cushion over a cricoid of the subject and to apply the pressure onthe neck that is transmitted to the esophageal sphincter of the subject.4. The method of claim 1 wherein: the clasp is configured to unfastenthe strap from the frame and to refasten the strap to the frame toreapply the pressure on the neck that is transmitted to the esophagealsphincter of the subject.
 5. The method of claim 1 wherein: the secondend section of the strap is looped through a slot of the clasp forsecuring the second end section of the strap to the frame.
 6. The methodof claim 1 wherein: the compression device further comprises anadjustment mechanism for moving the cushion toward or away from theframe.
 7. The method of claim 6 wherein: the adjustment mechanism isconfigured to perform micro-pressure adjustments to the pressure on theneck.
 8. The method of claim 1 wherein: step (b) further comprisesplacing an electrode in contact with the neck of the subject, placing anelectrical pulse generator in electrical communication with theelectrode, activating the electrical pulse generator to generate aseries of electrical pulses from the electrode such that the series ofelectrical pulses electrically stimulate the esophageal sphincter of thesubject, and the electrode is attached to the cushion.
 9. The method ofclaim 1 wherein: step (b) further comprises placing an electrodeadjacent or in the esophageal sphincter, placing an electrical pulsegenerator in electrical communication with the electrode, activating theelectrical pulse generator to generate a series of electrical pulsesfrom the electrode such that the series of electrical pulseselectrically stimulate the esophageal sphincter of the subject.
 10. Themethod of claim 1 wherein: the pressure on the neck that is transmittedto the esophageal sphincter of the subject induces an intra-luminalupper esophageal sphincter pressure to remain within a range that is10-70 mm Hg.
 11. A method for improving esophageal reflux disease of asubject, the method comprising: (a) providing a compression deviceincluding (i) a frame, (ii) a strap having a first end section attachedto the frame and an opposite second end section attached to the frame,and (iii) a cushion disposed on the frame; and (b) positioning thecompression device around a neck of the subject such that the cushionapplies pressure to a cricoid of the subject; and (c) repeating step (b)a plurality of times whereby the esophageal reflux disease of thesubject is improved.
 12. The method of claim 11 wherein: step (b) occurswhile the subject is sleeping.
 13. The method of claim 11 wherein: alength of the strap between the first end section and the second endsection is adjustable, a clasp is attached to the second end section ofthe strap; and the clasp is configured to fasten the strap to the frameto position the cushion over a cricoid of the subject and to apply thepressure on the neck that is transmitted to the esophageal sphincter ofthe subject.
 14. The method of claim 11 wherein: the clasp is configuredto unfasten the strap from the frame and to refasten the strap to theframe to reapply the pressure on the neck that is transmitted to theesophageal sphincter of the subject.
 15. The method of claim 11 wherein:the second end section of the strap is looped through a slot of theclasp for securing the second end section of the strap to the frame. 16.The method of claim 11 wherein: the compression device further comprisesan adjustment mechanism for moving the cushion toward or away from theframe, and the adjustment mechanism is configured to performmicro-pressure adjustments to the pressure on the neck.
 17. The methodof claim 11 wherein: the pressure applied to the cricoid of the subjectinduces an intra-luminal upper esophageal sphincter pressure to remainwithin a range that is 10-70 mm Hg.